Kornimate/medical-research-clean huggingface dataset:
incidence of lumbar spondylolisthesis in patients candidate for tkr

Conditions: Lumbar Spondylolisthesis

Summary: this study aims to detect the incidence of spondylolisthesis in patients candidate for total knee replacement (tkr) and to investigate the effect of tkr on the course of low back pain.

total knee replacement (tkr) is one of the most successful surgeries in modern-day orthopedics, performed mainly to treat end-stage knee osteoarthritis (oa) . degenerative spondylolisthesis is one of the most common causes of low back pain where a spinal vertebra slides from its anatomical position, affecting about 11.5% of the population, furthermore, many elderly patients undergoing tkr usually suffer from spondylolisthesis. spondylolisthesis with subsequent lumbar spine degenerative disease presents as lower back and radiating pain to the legs at rest or during activity, spondylolisthesis causes hamstring tightness which is felt as pain at the back of the knee, lumbar radiculopathy of the l3 root nerve could vary from thigh pain to hip and/or knee pain, all of which could be misled as pain due to knee oa . on the other hand, patients having knee oa with a flexion deformity compensate their posture by increasing the lumbar lordosis, if the lumbar spine lost its ability to compensate for the knee deformity, this could aggravate low back pain and enhance further lumbar spine instability and spondylosis . in addition, the persistence of coexisting lumbar spine symptoms after tka might adversely affect postoperative outcomes in terms of pain and function, even after successful tka . chang et al., studied the prevalence and severity of coexisting lumbar spondylosis in terms of radiographic lumbar spine degeneration and lumbar spine symptoms in patients with advanced knee oa undergoing tkr, in their study, 51% of patients undergoing tkr had at least one moderate to severe lumbar spine symptom, and patients with severe radicular pain on the activity before the tkr was likely to demonstrate poor knee function 2 years post-tkr . this is why lumbar spine pathologies should be fully investigated in patients coming for tkr.

Eligibility criteria:
inclusion criteria: * primary end-stage knee osteoarthritis. exclusion criteria: * secondary inflammatory knee osteoarthritis. * post traumatic knee osteoarthritis. * patients with active infection. * patients with poor general condition. * patients who had previous spinal fixation or fusion surgery.
situation awareness incorporating multidisciplinary teams reduce arrests in the pediatric icu

Conditions: In-hospital Cardiac Arrest; Cardiopulmonary Resuscitation

Summary: the goal of this pragmatic prospective type 1 hybrid implementation-effectiveness trial study is to learn if the situation awareness incorporating multidisciplinary teams reduce arrests in (samurai) the picu bundle can reduce picu cpr events. the samurai picu bundle includes an automated picu warning tool, twice daily huddles and mitigation plans. the main questions it aims to answer are: is the adapted bundle will be acceptable, feasible, and appropriate to stakeholders prior to implementation? will there be at least a 30% relative reduction in picu cpr events following successful implementation of the bundle? each site will: adapt and implement samurai picu bundle which includes an automated picu warning tool, twice daily huddles and mitigation plans

as nearly 95% of pediatric ihcas occur in picus, we developed an interventional cardiac arrest prevention bundle targeted to picu healthcare providers. in a previous single center trial, the use of the samurai picu bundle improved early identification of high-risk patients, increased shared situation awareness, and supported risk mitigation plans, leading to a \>50% decrease in ihca events requiring cardiopulmonary resuscitation (cpr). early identification occurs via the picu warning tool, an automated, electronic medical record clinical decision support tool that provides a non-interruptive notification to care providers of high-risk patients. this prediction tool prompts a bedside huddle to ensure shared situation awareness and development of a mitigation plan. this novel approach of emphasizing shared situation awareness through automated clinical decision support and mitigation of risk has demonstrated reduction in cpr events and mortality within the picu clinical environment. this study employs a user-centered design model to adapt, implement, and assess the feasibility and effectiveness of samurai picu at other pediatric institutions. the hypothesis is that identification of picu patients at high risk for ihca through the use of the picu warning tool and integration of this high-risk status in daily safety huddles will lead to improved shared situation awareness and subsequent reduction in cpr events at participating institutions. this approach will utilize a five-center pragmatic prospective hybrid type 1 effectiveness-implementation study leveraging the existing infrastructure of pediatric resuscitation quality collaborative (pedires-q).

Eligibility criteria:
inclusion criteria: * all patients admitted to the five picus in pedires-q during the study period exclusion criteria: * none

Keywords: situational awareness cardiac arrest cardiopulmonary resuscitation
cerebral lesion and neurocognitive status changes after tavr

Conditions: Aortic Stenosis

Summary: the clever-tavr cohort (cerebral lesion and neurocognitive status changes after transcatheter aortic valve replacement) is a multicenter observational cohort study. the investigators will screen consecutive patients ≥65 years of age before tavr and enroll those that complete the procedure successfully. the investigators will assess the neurocognitive function using multiple tests with reliable change index before tavr and 7, 30, 90, 180 and 360 days after tavr. the primary endpoint will be major adverse cardiovascular and cerebral events(macce, defined according to the valve academic research consortium-2 data dictionary) at 1 year.

study design the clever-tavr cohort (cerebral lesion and neurocognitive status changes after transcatheter aortic valve replacement) is a multicenter prospective observational study. patients with aortic stenosis who successfully undergo tavr procedure from january 2021 to december 2021 will be enrolled in this study according to the inclusion criteria. preoperative cognitive function, dw-mri evaluation and baseline data will be recorded. all patients should be followed up for 1 year, including telephone follow-up once a month to record the main end-point events, and clinic follow-up at 30, 90, 180, 360 days after tavr. laboratory examination, electrocardiogram, color doppler ultrasound and other examinations will be collected and recorded. the changes of cognitive function and brain imaging (dw-mri) will be evaluated before discharge(7 days), 30, 90, 180, 360 days after procedure. the primary endpoint will be major adverse cardiovascular and cerebral events(macce), including all-cause death, stroke, acute kidney injury, myocardial infarction, bleeding complications, vascular complications, permanent pacemaker implantation, conduction block and arrhythmia, valve related complications. the postoperative valve function, life quality and other complications related to tavr will also be recorded.

Eligibility criteria:
inclusion criteria: * patients voluntarily participated and signed informed consent; * patients with severe aortic stenosis undergo tavr after assessment by the heart team; \[definition of severe aortic stenosis: mean aortic pressure gradient (mpg) ≥ 40 mmhg, aortic valve area (ava) ≤ 1.0 cm2 and maximal aortic velocity (vmax) ≥ 4 m / s.\] ③ age ≥ 65 years old. exclusion criteria: * emergency procedure; * severe cognitive impairment (mmse \< 15), or years of education \< 6 years; * unstable condition (intractable angina pectoris, acute heart failure) or patients can not complete mri examination or cognitive assessment; * tavr operation failed or transferred to surgery for savr due to serious complications; ⑤ speech disorders, or mental disorders, or severe physical disorders (mrs ≥ 3); ⑥ patients with complicated congenital heart disease, hcm, surgery valve replacement or combined valvular disease; ⑦ patients with life expectancy less than 12 months.
treatment of impulsive aggression in subjects with adhd in conjunction with standard adhd treatment (chime 2)

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: the purpose of this study is to demonstrate the efficacy, safety, and tolerability of spn-810 in the treatment of impulsive aggression in patients with attention-deficit/hyperactivity disorder (adhd) in conjunction with standard adhd treatment. approximately 297 subjects aged 6 to 12 years with adhd and comorbid impulsive aggression will be recruited in this study. the frequency of impulsive aggression behaviors will be assessed as a primary outcome. additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.

this study is a randomized, placebo-controlled, double-blind, multicenter, parallel group, fixed dose study to demonstrate the efficacy, safety, and tolerability of spn-810 in the treatment of ia in subjects aged 6 to 12 years with adhd in conjunction with standard adhd treatment.

Eligibility criteria:
inclusion criteria: * otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of adhd and currently receiving monotherapy treatment with an optimized fda-approved adhd medication. * impulsive aggression will be confirmed at screening using r-moas and vitiello aggression scale. exclusion criteria: * current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, tourette's disorder, or psychosis not otherwise specified. * currently meeting dsm criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis. * known or suspected intelligence quotient (iq) \< 70, suicidality, pregnancy, or substance or alcohol abuse.
efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients

Conditions: Chronic Obstructive Pulmonary Disease Patients

Summary: the objectives of this study are to evaluate efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.

there are 72 patients in this study. they are randomly divided into 2 groups which are beta-glucan supplement group and placebo group. the supplement will be taken 1 capsule/day for 12 weeks. forced expiratory volume in 1 second/forced vital capacity, modified medical research council dyspnea score, breathlessness, cough, and sputum scale, 6 minute walk test, diffusing capacity for carbon monoxide, tumor necrosis factor alpha, interleukin-6, c-reactive protein, glutathione, aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine, and blood urea nitrogen are assessed before and after taking supplement 6 and 12 weeks.

Eligibility criteria:
inclusion criteria: * age more than 18 years * chronic obstructive pulmonary disease with forced expiratory volume in 1 second/forced vital capacity after receiving bronchodilator medicine more than 70% * no exacerbation and uncontrolled disease * 10 pack-years smoking history 10 pack-years but stop smoking more than 1 years * willing to participate in this study exclusion criteria: * respiratory infection in 4 weeks * lung cancer * liver disease or kidney disease * lung surgery history * take kung supplement in 2 weeks * take warfarin, clopidogrel, aspirin, or digoxin * allergic to beta-glucan, broccoli, or quercetin * cannot use spirometry * pregnancy and lactation

Keywords: chronic obstructive pulmonary beta-glucan
safety, tolerability, pharmacokinetics, and pharmacodynamics of incb099318 in participants with advanced solid tumors

Conditions: Advanced Solid Tumors; MSI-H/dMMR Tumors; Cutaneous Squamous Cell Carcinoma; Urothelial Carcinoma, HCC; Cervical Cancer; Esophageal Squamous Cell Carcinoma; Merkel Cell Carcinoma; Small-cell Lung Cancer; Mesothelioma; PD-L1 Amplified Tumor (9p24.1); Nasopharyngeal Carcinoma; Cyclin-dependent Kinase 12 Mutated Tumors; Basal Cell Carcinoma (Unresectable or Metastatic); Sarcomatoid Renal Cell Carcinoma; Clear Cell Ovarian or Endometrial Carcinoma; Anal Carcinoma; Squamous Cell Penile Carcinoma; DNA Polymerase Epsilon Mutated Tumors (P286R and V411L)

Summary: the purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of incb099318 in select solid tumors.


Eligibility criteria:
inclusion criteria: * must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment. * histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per response evaluation criteria in solid tumors version 1.1 (recist v1.1) that are considered nonamenable to surgery or other curative treatments or procedures. * ecog performance status score of 0 or 1. * life expectancy \> 12 weeks. * willingness to avoid pregnancy or fathering children. exclusion criteria: exclusion criteria: * laboratory values outside the protocol-defined ranges. * clinically significant cardiac disease. * history or presence of an ecg that, in the investigator's opinion, is clinically meaningful. * untreated brain or central nervous system (cns) metastases or brain or cns metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or cns metastases). * known additional malignancy that is progressing or requires active treatment. * has not recovered to ≤ grade 1 or baseline from toxic effects of prior therapy (including prior io) and/or complications from prior surgical intervention before starting study treatment. * prior receipt of an anti-pd-l1 therapy. * treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * a 28-day washout for systemic antibiotics is required. * probiotic usage while on study and during screening is prohibited. * active infection requiring systemic therapy. * known history of hiv * evidence of hepatitis b virus or hepatitis c virus infection or risk of reactivation.

Keywords: advanced solid tumors
study of fluticasone propionate/salmeterol in asthmatic subjects

Conditions: Asthma

Summary: the aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.

a 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum il-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval

Eligibility criteria:
inclusion criteria: * informed consent. * outpatient. * male or non-pregnant/non-lactating female. * aged 18-55. * diagnosis of asthma. * pre-bronchodilatory fev1 \> 75% predicted. * using inhaled short-acting beta-2-agonists (saba) with no inhaled corticosteroids. * judged capable of withholding saba for at least 6 hours prior to visits. * reversibility of \>12% and 200ml or pc20 of \<8mg/ml. * demonstration of atopy exclusion criteria: * history of life-threatening asthma. * use of proscribed asthma medications. * use of anti-histamines or potent inhibitors of cyp3a4. * respiratory tract infection. * asthma exacerbation with 4 weeks of visit 1. * subjects with exercise induced asthma only. * concurrent respiratory disease. * other clinically significant, uncontrolled condition or disease. * use of any investigational drug within 30 days. * allergic to beta-2-agonists, inhaled corticosteroids or excipients. * positive pregnancy test. * using immunosuppressive medications. * milk protein allergy. * factors likely to interfere with attendance. * current smokers or ex-smokers with a history of \>10 pack years. * affiliation wih investigator site. * medications that may affect the course of asthma or interact with sympathomimetic amines.

Keywords: asthma allergen challenge il-5 eosinophils
study of nitazoxanide, peginterferon, and ribavirin combination therapies in the treatment of chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis c genotype 4. the study will also evaluate the effect of the studied treatment regimens on end of treatment virologic response, alt normalization and safety parameters.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * chronic hepatitis c infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-hcv-antibodies and a positive quantitative rt-pcr amplification of hcv rna. * chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis. * hcv genotype 4. exclusion criteria: * patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy. * females who are either pregnant, breast-feeding or not using birth control and are sexually active. * males whose female partners are pregnant. * patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease). * patients co-infected with hepatitis a virus, hepatitis b virus or hepatitis d virus. * patients with a history of alcoholism or with an alcohol consumption of \>40 grams per day. * patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia). * patients with any concomitant condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. * history of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets.

Keywords: hepatitis c
opioid antagonism in hypogonadotropic hypogonadism

Conditions: Hypogonadotropic Hypogonadism

Summary: the goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with idiopathic hypogonadotropic hypogonadism (hh).

assignment: each study subject will serve as their own control. delivery of interventions: * prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. * during the study, the subjects will undergo the following: * period 1: undergo q10 min blood sampling for up to 12 hours * period 2: undergo q10 min blood sampling for up to 12 hours * receive a naloxone bolus followed by a naloxone infusion

Eligibility criteria:
inclusion * age 18-75 years * confirmed diagnosis of hypogonadotropic hypogonadism * genetic sequencing data available * all medical conditions stable and well controlled * if applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation * normal blood pressure (systolic bp \< 140 mm hg, diastolic \< 90 mm hg) * negative urine drug screening panel * hemoglobin * women: no less than 0.5 gm/dl below the lower limit of the reference range for normal women * men on adequate testosterone replacement therapy: normal male reference range * men off testosterone replacement therapy: no lower than 0.5 gm/dl below the lower limit of the reference range for normal women * for women, negative serum hcg pregnancy test exclusion * any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol * current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration * current or recent use of a medication that affects the opioid pathway * active illicit drug use * excessive alcohol consumption (\> 10 drinks/week) * for women, pregnant or breastfeeding

Keywords: hypogonadotropic hypogonadism naloxone
effect of domperidone on the nutrient composition of preterm mother's breast milk

Conditions: Low Breast Milk Supply

Summary: the purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.

domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. it has been shown to safely increase the milk supply of lactating women. to date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. however, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. the purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.

Eligibility criteria:
inclusion criteria: * i. mother of an infant born less than 31 weeks gestation * ii. women mechanically expressing breast milk using a double collecting system * iii. experiencing lactation failure indicated by at least one of the following: a decreasing milk supply (by greater than 30 percent from peak volume based on maternal account) an inability to provide adequate breast milk to meet the daily nutritional intake of their infant * iv. women who have had little or no improvement in milk production following education/counseling with a lactation consultant/neonatal intensive care nurse with respect to non-pharmacological techniques. * v. postpartum period equal to or greater than three weeks. exclusion criteria: * i. participants receiving any medication known to alter the effect of domperidone (e.g.cimetidine, ranitidine, famotidine, and nizatidine) or medication that interacts with domperidone (e.g. haloperidol, lithium). * ii. experiencing mastitis * iii. having a chronic or debilitating illness. * iv. previous breast surgery * v. having a known lactose intolerance

Keywords: domperidone breast milk breast milk composition preterm infant neonate nutrition